Design Quality Assurance Specialist

1 week ago


Westford, Massachusetts, United States Mondo Full time
Design Quality Engineer

Mondo is seeking a skilled Design Quality Engineer to join our team. As a key member of our team, you will be responsible for ensuring the quality and integrity of our medical devices.

Key Responsibilities:
  • Document review and risk management
  • Implementation of CAPAS and change management
  • Collaboration with R&D to identify qualification work and end-of-life related issues
  • Development and maintenance of design history files
  • Standards assessment and design integrity evaluation
Requirements:
  • 2+ years of experience in design for medical devices
  • Knowledge of design controls and external standards (e.g. EUMDR)
  • CAPAS resolution plans and standards changes
  • Six sigma problem-solving and hands-on design V&V
  • Risk management and design FMEA process
Preferred Qualifications:
  • Greenbelt certification
  • Risk management experience

Mondo offers a competitive compensation range of $35-40 per hour W2, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and design, we encourage you to apply for this exciting opportunity.



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